Medical Device Registration in


Ministry of Health

Ministry of Health of Uganda

Regulatory Authority

National Drug Authority (NDA)

Medical Device Regulation

  1. Ministerial decree ADM.140/323/01 of 20th July 2020

Official Language

English, Swahili


Class A, B, C, D

Medical Device Registration in Uganda

  • Determine the medical device classification
  • Appoint your Authorised Representative in Uganda
  • Registration can be via:

Track 1 – for products approved in IMDRF countries

Track 2 – for products prequalified by WHO

Track 3 – for products with no prior approval

  • The registration will be done via NDAMIS portal
  • Once approved, the device can be marketed in Uganda

Documents Required

  • Accurately detail application letter (Hard and soft copy)
  • Bank deposit slip (prove of payment)
  • Sample of the product (if applicable)
  • Documentation/Dossier
  • Prior market history and approvals

Post-market Requirements

Adverse Event Reporting

Authorized Representative


License Validity

5 years

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